Health, drug supervision, quality and technical supervision and other relevant administrative departments and supervising agencies for animal epidemic prevention shall, according to their respective duties, do a good job in the management of experimental animals. Article 4 Units and individuals that raise, breed and manage experimental animals (hereinafter referred to as experimental animal production units) shall meet the following conditions:
(1) Having facilities and testing means to ensure the quality of experimental animals;
(2) Feed, drinking water, padding, etc. Meeting the prescribed standards;
(3) Having a sound quality management system and operating procedures;
(four) professional and technical personnel, testing personnel and aquaculture personnel who have obtained qualification certificates;
(5) The seeds come from the National Center for the Protection of Experimental Animals or its recognized provenance units with clear genetic background;
(6) The quality of the experimental animals produced meets the legal standards;
(seven) other conditions stipulated by the state. Article 5 An entity that uses experimental animals for scientific research, teaching or verification of drugs, biological products and other products (hereinafter referred to as experimental animal users) shall meet the following conditions:
(a) the environmental facilities of the animal laboratory meet the prescribed standards;
(2) The experimental animals are from the units that hold the production license of experimental animals and have the quality certificate;
(3) Feed, drinking water, padding, etc. Meeting the prescribed standards;
(four) a sound quality management system and operating procedures;
(5) Having laboratory animal breeders and laboratory personnel who have obtained qualification certificates;
(6) Other conditions stipulated by the state. Sixth experimental animal quality, environmental facilities and feed, by the provincial experimental animal quality testing institutions for testing.
The quality inspection of experimental animals shall be carried out in accordance with national standards; There is no national standard, the implementation of industry standards.
Quality inspection institutions must issue inspection reports objectively and fairly, and may not forge inspection data and conclusions. Seventh experimental animal production and use units shall apply to the provincial administrative department of science and technology for the production license or use license of experimental animals.
To apply for a production license for experimental animals, it shall submit the proof of the seed source of experimental animals, the inspection report of environmental facilities of legal inspection institutions and the quality inspection report of experimental animals; To apply for a license for the use of experimental animals, a copy of the production license of experimental animals from the unit where the experimental animals originated, the quality certificate of experimental animals and the environmental facilities inspection report of the statutory inspection agency shall be submitted. Article 8 The provincial administrative department of science and technology shall, within 60 days from the date of receiving the application and relevant materials submitted by the production and use units of experimental animals, organize relevant experts to conduct examination and make a decision on approval or disapproval. If approved, an experimental animal production license or an experimental animal use license (hereinafter referred to as the experimental animal license) shall be issued; If it is not approved, it shall explain the reasons in writing. Ninth experimental animal license is valid for 5 years. The production and use units of experimental animals shall apply to the provincial administrative department of science and technology for renewal within 6 months before the expiration of the validity period. The provincial administrative department of science and technology shall go through the renewal procedures in accordance with the provisions of Article 8.
The license for experimental animals shall not be altered, lent, leased or transferred. Tenth experimental animal production and use units need to increase the experimental animal license registration items, it shall apply to the provincial administrative department of science and technology. The provincial administrative department of science and technology shall, within 30 days from the date of receiving the application, organize experts to carry out the examination, and go through the formalities for change if they pass the examination.
Where the production and use units of experimental animals stop engaging in the registration of experimental animal licenses, they shall return the experimental animal licenses to the issuing departments within 30 days after stopping. Eleventh experimental animal production units in the sale of experimental animals, experimental animals must provide quality certificates.
The quality certificate of experimental animals shall include the following contents:
(a) the serial number of the experimental animal production license;
(two) the name and grade of the variety and strain;
(3) Genetic background or source;
(four) the date and results of microbial and parasitic detection;
(5) Signature of the person in charge of the unit. Twelfth experimental animals are divided into ordinary level, clean level, no specific pathogen level and aseptic level.
Ordinary experimental animals are raised and bred in ordinary environment; Laboratory animals with clean grade and no pathogens are raised and bred in a barrier environment; Sterile experimental animals are raised and bred in an isolated environment. Specific environmental standards shall be implemented in accordance with relevant state regulations. Thirteenth the location and layout of the breeding and feeding environment of various experimental animals and the cage area occupied by experimental animals shall comply with the relevant provisions of the state and province.
The same laboratory shall not conduct animal experiments of different varieties, grades and mutual interference at the same time. Article 14 Units using experimental animals shall use qualified experimental animals of corresponding grades according to different experimental purposes and relevant technical specifications.
If the grade of experimental animals used does not meet the relevant specifications, or the unqualified experimental animals are used for product verification or safety evaluation, the verification or safety evaluation results obtained are invalid, and the drugs, biological products and other products produced shall not be provided for use.